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Keyword: fda

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  • E-cigarettes will get FDA oversight as tobacco products

    04/26/2011 3:10:05 AM PDT · by Tolerance Sucks Rocks · 25 replies
    The Los Angeles Times ^ | April 25, 2011 | Melissa Healy
    The Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up. In a letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. To shore up its authority to do so, the agency will propose new regulatory language that would specifically define...
  • US to regulate electronic cigarettes as tobacco

    04/25/2011 11:46:02 PM PDT · by bruinbirdman · 25 replies
    The Telegraph ^ | 4/26/2011
    The U.S. Food and Drug Administration's announcement came after the U.S. Court of Appeals for the D.C. Circuit issued a decision which said that electronic cigarettes are not drugs or devices unless they are marketed for therapeutic purposes. In 2009, the FDA was given the authority to regulate tobacco products that are not drugs or devices. Electronic cigarettes, marketed under names such as NJOY, mimic the act of smoking and include nicotine, but do not emit the same type of odour or ash. In December, three judges from the appellate court ruled that the FDA could regulate the products as...
  • Small Businesses Fret Over Food-Safety Rules

    04/22/2011 1:17:29 PM PDT · by Qbert · 8 replies
    WSJ ^ | 4/22/2011 | STEPHANIE GLEASON
    When Congress revamped food-safety laws last year, small farmers and food producers won a victory when they were excluded from many of the new rules. Now, as the Food and Drug Administration implements the new Food Safety Modernization Act, the small businesses are hoping they aren't snagged by the new rules anyway. The legislation, which updates 100-year-old food-safety regulations, does not apply to meat, eggs or dairy products, which are regulated by the U.S. Department of Agriculture. Despite the exemption, it's still unclear how small food producers will be affected, said Robert Guenther, senior vice president of public policy for...
  • Obama Health Bill Sends "Yankees" Peanut Factory Packing (FDA regs required $40 M factory update)

    04/21/2011 6:18:45 PM PDT · by Qbert · 21 replies ^ | 4/21/2011 | Garth Johnston
    The FDA Food Safety Modernization Act that President Obama signed into law this year didn't just bring us a fancy new FDA recall page. It also is sending the 125-year-old A.L. Bazzini Co., which makes the “official peanut of Yankee Stadium,” out of New York and into the loving embrace of Pennsylvania. The firm, which moved from TriBeCa to Hunts Point in 1997, says the new regulations would require them to perform a $40-million-dollar update to their production facility. And since they have this "state of the art" plant in Allentown (thanks to their recent purchase of the chocolate company...
  • Rx Drug Shortages Hit All-Time High

    04/20/2011 4:15:05 PM PDT · by bvw · 87 replies · 1+ views
    MedPage Today ^ | March 28, 2011 | Emily P. Walker
    WASHINGTON -- The number of prescription drugs in short supply has more than tripled since 2005 and shortages are now more frequent than ever, [] Premier Healthcare Alliance -- a performance improvement alliance of more than 2,500 U.S. hospitals -- surveyed 311 pharmacy experts at hospitals and other facilities, such as surgery centers and long-term care facilities, about shortages during a six month period in 2010. The survey found that 89% had experienced shortages that may have caused a medication safety issue or error in patient care. Eight out of 10 times a shortage occurred, the patient's care was delayed...
  • Senator urges FDA to ban menthol-flavored cigarettes

    04/20/2011 6:19:54 PM PDT · by Tolerance Sucks Rocks · 49 replies · 1+ views
    The Hill ^ | April 19, 2011 | Josiah Ryan
    Sen. Richard Blumenthal (D-Conn.) is calling on the Food and Drug Administration (FDA) to ban menthol-flavored cigarettes. In a letter addressed Monday to the FDA, Blumenthal said the agency should ban menthol cigarettes because they encourage young people to smoke. “The dangers of menthol tobacco products in general, and to our youth in particular, are highly concerning, and provide abundant grounds for FDA to develop a plan that will result in the removal of menthol from tobacco products to protect public health,” Blumenthal wrote in the letter, addressed to FDA Commissioner Margaret Hamburg. Blumenthal is seeking a ban identical to...
  • Obama tries to obstruct executions

    04/17/2011 6:33:51 PM PDT · by SmithL · 30 replies
    San Francisco Chronicle ^ | 4/17/11 | Debra J. Saunders
    President Obama well may have begun another undeclared war - this time on states that try to enforce their own death penalty laws - on the dubious grounds that the Food and Drug Administration has not approved drugs intended to kill convicted killers. On March 15, the Drug Enforcement Administration seized Georgia's supply of sodium thiopental, the first drug given under the three-drug lethal injection protocol used in most of the country's 34 death-penalty states. The DEA also asked Kentucky and Tennessee for their sodium thiopental to aid its investigation. Why? The DEA referred me to the Department of Justice,...
  • Free Speech in Health Science May Become a Reality (Proposed law to curb FDA limits on speech)

    04/06/2011 12:59:50 AM PDT · by UnwashedPeasant · 4 replies
    Today, the Free Speech about Science Act of 2011 was introduced in Congress by Rep. Jason Chaffetz (R-UT) and Rep. Jared Polis (D-CO). Please tell Congress how important this bill is!As we reported last week, a new bill in Congress promises to revolutionize the way Americans get access to scientific research on the health benefits of foods and supplements. The Free Speech about Science (FSAS) Act, HR 1364, would change FDA regulations so that legitimate, peer-reviewed scientific studies can be referenced without changing the food’s regulatory category to an unapproved drug. This will protect access to scientific information, and will...
  • FDA Headbangs With Condoms, Not Cigs

    03/28/2011 8:00:26 AM PDT · by Kaslin · 18 replies · 1+ views ^ | March 28, 2011 | Katie Kieffer
    If young people have casual sex, they’re rock stars, as long as they use condoms. If they casually smoke cigarettes, they’re borderline criminals. According to the FDA, that is. The FDA takes a hypocritical and overly invasive stance on two adult products: Condoms and cigarettes. The FDA’s inconsistent and excessive regulation of these adult products hurts free enterprise and represents an inappropriate extension of government in our daily lives. This month, The Associated Press reported that condom maker Graphic Armor Inc. is releasing the first line of FDA-compliant condoms with full-color advertising graphics directly on the latex. The graphics will...
  • The FDA’s Genetic Paternalism - Stifling research, costing Americans more, and sending them into...

    03/25/2011 1:47:06 PM PDT · by neverdem · 6 replies
    NATIONAL REVIEW ONLINE ^ | March 23, 2011 | Robert VerBruggen
    The FDA's Genetic PaternalismStifling research, costing Americans more, and sending them into the black market — some likely consequences of overregulation Ever wonder why your hair is the color it is, where your remote ancestors resided, or whether you carry genes for diseases that could affect you or your children? As of today, it’s not possible to know all of that with certainty — not even close. But you can get a few answers by sending a saliva sample to a private company and paying it to analyze your DNA. Even better, as new research becomes available, you can check...
  • CBS Touts FDA Taking On 'Caloric Catastrophe' of Movie Theater Popcorn

    03/24/2011 3:18:39 PM PDT · by Nachum · 36 replies · 1+ views
    Newsbusters ^ | 3/24/11 | Kyle Drennen
    In a report for Thursday's CBS Early Show, contributor Taryn Winter Brill fretted over the impact of movie theater popcorn on Americans' waistlines: "Have you ever wondered how many calories you're actually consuming in that large popcorn with butter? You probably don't want to know. Pretty soon, though, you may not have a choice." Moments later, nutritionist Katherine Brooking declared the popular concession treat to be "a calorie bomb waiting to explode." Brill then touted a government solution to the problem: "Hoping to defuse this high caloric catastrophe, the FDA is working on a provision in the health care law...
  • How the FDA Turned a $10 Treatment into a $30,000-Per-Pregnancy Pharmaceutical Money-Maker

    03/23/2011 7:02:48 AM PDT · by La Lydia · 45 replies
    ANH ^ | March 20, 2011
    When a new FDA drug-and-money scandal has doctors, US senators, and even the March of Dimes in an uproar, you know it’s bad. A drug which the FDA approved more than half a century ago—which doctors have been prescribing for their patients with high-risk pregnancies through compounding pharmacies with great success—was designated by the FDA an “orphan drug.” Now KV Pharmaceutical has been given the exclusive right of production and sale (not to mention drug trial tax breaks!). They immediately raised the price from $10 per dose to $1,500—simply because they could. The drug is a synthetic form of progesterone...
  • How to Speed Up the Drug Approval Process

    03/19/2011 6:02:49 AM PDT · by Kaslin · 6 replies
    Pajamas Media ^ | March 19, 2011 | Horace Cooper
    America canÂ’t afford to have a health care system where it is acceptable to let people suffer or die due to delay in receipt of drugs. Unless you are an asthma sufferer, you probably didnÂ’t see the Food and Drug AdministrationÂ’s (FDA) recent announcement that beginning next year it will ban the sale of Primatene Mist, the only over-the-counter asthma inhaler sold in the United States.Do new tests show that the drug is harmful or that there are unanticipated side effects? No. In fact, Primatene Mist has proven to be one of the most effective treatments for temporary asthma symptoms....
  • [Posted March 17, 2011] Environment Trumps Health As FDA Ends Sales of Only OTC Asthma Inhaler in U.

    03/18/2011 11:41:18 AM PDT · by Nachum · 84 replies
    CNS News ^ | 3/17/11 | Susan Jones
    ( - The only over-the-counter asthma inhaler sold in the United States soon will be banned from store shelves because of environmental concerns, and replacement medications may cost more, the U.S. Food and Drug administration acknowledged. The FDA announced on Wednesday that Primatene Mist (epinephrine) will be discontinued by the end of the year, as part of an international agreement to phase out chlorofluorocarbons and other ozone-depleting substances. Primatene Mist, approved by the FDA for the temporary relief of occasional symptoms of mild asthma, uses chlorofluorocarbons as a propellant.
  • US takes over three Tylenol plants

    03/10/2011 5:30:40 PM PST · by MamaDearest · 57 replies ^ | March 10, 2011 | Parja Kavilanz
    Excerpt only website: The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories. The FDA and the Justice Department on Thursday took action against McNeil PPC and two of its executives -- its vice president of quality and its vice president of operations for over-the-counter products -- for failing to comply with federally-mandated manufacturing practice. McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), said it had agreed to put its plants -- one in Las Piedras, Puerto Rico, one in...
  • DA Orders Prescription Cold, Allergy Medicines Off the Market

    03/02/2011 6:48:03 PM PST · by wastedyears · 14 replies
    AOL ^ | March 2, 2011 | Marrecca Fiore
  • EPA Reverses Itself on Fluoride

    02/28/2011 6:18:08 PM PST · by DBCJR · 214 replies ^ | February 22, 2011 | By Deirdre Imus
    For decades, fluoride has been marketed and heralded as essential for good dental hygiene and used in most toothpastes and mouthwashes. In addition, parents have been routinely encouraged to give their kids cavity-fighting fluoride treatments when they visit the dentist. ... But that was then and this is now. In a surprising reversal, last month EPA’s announced that it intends to lower the maximum amount of fluoride in drinking water because of growing evidence supporting the chemical’s possible deleterious effects to children’s health. In 2006, the National Academy of Sciences report that found dental fluorosis – caused by too much...
  • The FDA and Slower Cures

    The bureaucratic assault on cancer treatments. The White House now claims it is so alarmed about declining private pharmaceutical research that the government must create a new multibillion-dollar R&D center. Perhaps it should consult the Food and Drug Administration, which thinks it is approving too many new drugs, especially for serious diseases like cancer. That's the message of this month's remarkable FDA hearing to grill six major drug makers on the alleged shortcomings of the "accelerated approval" process. Congress created this fast-track for promising drugs for unmet medical needs in 1992, but the FDA bureaucracy thinks it is too friendly...
  • And So Rationing Begins: ObamaCare vs. Breast Cancer Patients

    02/26/2011 6:13:45 AM PST · by Kaslin · 33 replies · 2+ views ^ | February 26, 2011 | Garrett Murch
    Influenced by the president’s mandate to “bend the health care cost curve,” the Food and Drug Administration (FDA) is preparing to deny late-stage breast cancer patients access to the critical, but expensive, life-extending drug Avastin. The FDA wants to “de-label” the drug, a move that would force patients with insurance or Medicare coverage to pay for the drug out of their own pocket in order to survive. Now patients groups are speaking out. Led by the Susan B. Komen Foundation for a Cure, 15 patient advocacy groups have petitioned the FDA to reverse their effort to ration the drug. In...
  • FDA knew of problems at plant that made tainted alcohol wipes (But sent no warning letters)

    02/22/2011 6:50:59 AM PST · by Qbert · 19 replies
    MSNBC ^ | 2/22/2011 | JoNel Aleccia
    The death of a 2-year-old Houston boy from a rare infection blamed on contaminated alcohol wipes may be only the first casualty tied to allegedly shoddy sterilization practices by a Wisconsin medical products firm. Since reported Feb. 15 about the death of Harrison Kothari , who was infected with the same type of rare bacteria that sparked the recall of tens of millions of pads and swabs, dozens of people have stepped forward to say they may have been sickened, too. At the same time, government documents obtained by showed that federal Food and Drug Administration inspectors knew...